← Back to catalogue
Sharay Anti-Histones IgG (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 11104007Ref 14000723
Identity
- Trade Name
- Sharay Anti-Histones IgG (CLIA) EUDAMED
- Device Name
- Sharay Anti-Histones IgG (CLIA) EUDAMED
- Model / Reference
- 11104007 EUDAMED14000723 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070761288 EUDAMED06975070769321 EUDAMED
- Basic UDI-DI
- B-06975070761288 EUDAMEDB-06975070769321 EUDAMED
- EMDN Code
- W0102100107 HISTONES (H1, H2A, H3, H4,…HN) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Sharay Anti-Histones IgG (CLIA) by C-Luminary Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06975070761288 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- C-Luminary Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000035089
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (2)
- EUDAMED 9ff29d9e-0b14-41d6-9338-197d96cb64d8 61 fields · synced Jul 13, 2026
- EUDAMED d247a8e0-806a-43fe-9e3d-e360e5069722 61 fields · synced Jul 13, 2026